THE OPPORTUNITY
PMI has always been a leading company in the sector, but the time of transformation we are currently experiencing is quite exciting and is unprecedented. We are facing one of the greatest transformations in the history of fact-moving-consumer-goods, and the creation of a vision of a smoke-free future requires enormous courage, resourcefulness and motivation. Our organization stands for continuous improvement and therefore we not only try to improve in products but in our work too. Did you know we have awards for Equal Pay and Top Employer?
THE OPPORTUNITY In your new role as Batch Record Reviewer you will be responsible for the review and release of batch records, Certificates of analysis and other pertinent document and relaying this information to the appropriate departments. As the Batch Record Reviewer you will ensure all relevant standards are respected along the manufacturing process and provide support to QA and Production teams to analyze nonconformities and to identify improvement opportunities. Perform critical review of executed batch production records while managing intermediate and finished product non conformities and related corrective and preventive actions held and ultimately confirms to the final approver that the product can be released for commercial manufacturing. Provide reports and technical support to relevant departments related to quality performance and assessment of the product quality in line with QMS procedures.
RESPONSIBILITIES
- ANALYZE & REPORTING: Provide support on report generation and data analysis, when required by ensuring the compliance and integrity of data. Support the monitoring of the different QA KPI’s.
- QA SUPPORT: Provide QA support and expertise in order to improve products and quality systems. Ensure timely quality support in case of any quality problems encountered on products, providing quality risk assessment and an accurate action plan/solution that immediately reduces the negative impact on the Quality and Production KPI’s. Provide on floor support in the implementation of quality standard and self-control system in order to ensure that the products and the processes meet the quality requirements all along the manufacturing line.
- NON-CONFORMITIES & CAPA: Establish a system to identify and segregate all non-conforming intermediate and finished products whether identified at warehouse, at laboratory, on the floor or post production. Investigate and resolve critical deviations, define disposal actions and when appropriate corrective actions. Define and implement a monitoring system of manufactured products through appropriate historical data and trend analysis to identify potential deviations and preventive actions (CAPA). Ensure execution and update of QA reports.
- CONTINUOUS IMPROVEMENT & INNOVATION: Challenge all the standard processes and products in order to propose productivity initiatives. Support the work team to plan the tests and the analyses needed availing yourself of the concept of: Total Quality, Lean Manufacturing and Total Productive Maintenance (TPM).
- COMMUNICATION & COOPERATION: Communicate all useful information for the good flow of QA processes to concerned colleagues and to support teams in order to meet productivity, quality. Provide support during product and process improvement test and new platform development. Support QA Engineers to define new quality standards for new products.
- RRP BATCH RECORD DOCUMENTATION: Support the manufacturing team in the establishment and revision of the batch documentation, providing guidance on data and record management. Ensure manufacturing batch Record and Batch release documentation is accurate, complete, reviewed and archived in line with PMI guideline and QMS requirements to ensure confirmation that the product can be released for commercial manufacturing.
- TRAINING: Execute internal training to manufacturing employees, as subject matter expert in quality process and product, in order to enhance their overall level of quality awareness.
- HEALTH, SAFETY AND ENVIRONMENT: Promote and apply all rules concerning PMI quality, environment, health and safety. Report all situations requiring actions in order to minimize or eliminate risks, exposure to personnel, company assets and societal impacts and be in line with or ahead of any applicable law requirements and company standards.
RISE TO THE CHALLENGE
You will join a dynamic, international and fast-paced work environment in a constantly evolving industry and will interact with different levels of experience and expertise across the company. Our company offers you a fresh perspective. Here, you will never stop exploring and discovering. We take on-the-job learning to another level, giving you every opportunity to develop your career and reach your full potential. This position will advance your experience with innovative technologies, services, and processes. Backed by a competitive salary and compensation package, you will work in a professional setting with clients and team members from all over the world. * Reduced-Risk Products (“RRPs”) is the term we use to refer to products with the potential to reduce individual risk and population harm in comparison to smoking combustible cigarettes.KEY REQUIREMENTS
- You hold a Bachelor or Master degree in Chemical Engineering, Biological / Science, Laboratory or equivalent;
- 2+ years’ of experience in production, quality or equivalent department;
- You have solid experience working in Pharma, Chemical or FMCG environment;
- You have a natural affinity for PC tools. Professional knowledge of SAP, MES and MS Office (Excel);
- Knowledge of relevant standards (ISO), QA processes, statistical and analytical tools;
- Strong reporting skills;
- Knowledge on pharmaceutical and/or medical device industry regulations would be considered as an additional asset.
- Fluent level of written and spoken English and Dutch.
